The need for continuous improvement in product quality, reliability, and safety arises due to recalls, updates of Regulatory requirements, and the desire to gain a competitive advantage. The newly introduced changes may alter the risk profile of the device, and the device manufacturers must revisit risk evaluations that pinpoint and reduce part or system failures over the product's lifecycle.
- November 22, 2022 Medical Devices, Regulatory Affairs
- November 21, 2022 Biologicals, Generics, Pharmaceuticals
DYK? The National Medical Products Administration (NMPA), along with China National Intellectual Property Administration (CNIPA), has released “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)." It is a patent registration platform for chemical drugs, biological products, and traditional Chinese medicines.
- November 21, 2022 Medical Devices, Regulatory Affairs
With the enactment of NMPA’s Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device registration process.
- November 17, 2022 Medical and Scientific Communication, Regulatory Medical Writing
The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific editors.
- November 16, 2022 Regulatory Artwork Services, Regulatory Affairs, Regulatory Labeling
As the world is moving towards digital transformation, the introduction of various tools is empowering many industries, including Pharmaceuticals and Life Sciences. In fact, the serialization and traceability of items can be improved even further as the world transitions to a digital economy.
- November 16, 2022 Medical Devices, Regulatory Affairs
Brazil is the largest economy in Latin America and the most promising medical device market. Medical device market in Brazil is governed by the Brazilian Health Regulatory Agency, ANVISA. The ANVISA came up with a new resolution, RDC 687/2022, for granting or renewing the Brazilian Good Manufacturing Practice (BGMP) certification for medical devices and is in effect from June 01, 2022, annulling RDC 183/2017.
- November 15, 2022 Medical Devices, Regulatory Affairs
The medical device industry landscape is ever-changing owing to globalization and the advent of newer technologies. Due to these constant changes and developments, medical device organizations need robust change management systems.
A change can be prompted at various stages of the medical device life cycle. Some of the common events that can act as ‘triggers for changes include the following:
- November 11, 2022 Regulatory Affairs, Regulatory Medical Writing
Drug Development Technologies (DDTs) are methods, materials, or measures that assist in drug development and Regulatory review, as stated in the 21st Century Cures Law. These include biomarkers, clinical outcome evaluations, and other metrics.
- November 11, 2022 Regulatory Affairs, Regulatory Software & Services
Pharmaceutical professionals in the Regulatory space face complicated, rigorous, and ever-evolving requirements for the Regulatory approval of products in any market. But as technology advances, our ability to obtain data from other sources also changes. The amount of data in the Life Sciences industry is rising exponentially.
- November 9, 2022 Pharmaceuticals, Regulatory Affairs, Health Authority Updates
As per the recent update from the Danish Medicines Agency (DMA) dated October 19, 2022, the deadline for submitting marketing authorization and clinical trial applications has been revised to December 20, 2022. The move comes as the DMA will be closed from December 24 to January 01, 2023, for the Holiday Season.